Kornimate/medical-research-clean huggingface dataset:
airflow limitation in cardiac diseases in europe

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this is a cross-sectional, observational study, investigating the point prevalence of airflow limitation in current or former smokers with established ischemic heart disease. the study will recruit up to 3000 patients from cardiology clinics at hospitals across europe.

airflow limitation (al) occurs in a number of respiratory diseases including asthma and copd; in middle-aged and older patients it typically represents chronic obstructive pulmonary disease (copd), and is associated with a high degree of co-morbidity which includes cardiovascular diseases (cvd) and risk factors such as hypertension and diabetes. copd often goes undiagnosed, especially in patients with established coronary disease because copd and cardiovascular diseases share a major etiological factor: smoking. this cross-sectional, observational study, investigating the prevalence of al in current or former smokers with established ischemic heart disease, aims increase the knowledge and understanding of copd in this patient population, and to highlight the burden of comorbid disease in these patient

Eligibility criteria:
inclusion criteria: * subjects aged ≥40 years; * current or former smokers with ≥10 pack years; * subjects attending outpatient cardiac clinic (or equivalent) fulfilling any of the following criteria: 1. documented history of an ischemic event, 2. current diagnosis of stable ihd (including history of acute myocardial infarction (mi) and angina pectoris) as diagnosed in accordance with esc guidelines 3. receiving regular therapy for ihd for \>1yr, subjects meeting these criteria will be eligible for the study, even if they have other cardiac diseases or other co-morbidities; * subjects willing and able to sign study consent form. exclusion criteria: * subjects for whom spirometry is contraindicated; * subjects with recent surgery or mi (within 1 month); lower respiratory tract infection or pneumothorax (within 2 months); or stroke (within 12 months); * subjects with a pre-existing condition which, in the opinion of the investigator, would compromise the safety of the subject in this study

Keywords: prevalence copd emphysema co-morbidities ischemic heart disease chronic bronchitis spirometry burden
neuropattern™ for workplace health promotion

Conditions: Stress-Related Disorder

Summary: neuropattern™, a new diagnostic tool for stress related disorders is being applied in a demanding workplace environment. neuropattern™ aims at identifying stress-related bodily changes at an early stage. by identifying subgroups based on neuropattern™ subjects gain access to online counseling specified according to their neuropattern™ diagnosis. efficacy is being assessed by several questionnaires in a follow-up.

100 employees of a company in rhineland palatinate employing approximately 2100 persons will be recruited. this is a randomized, two-armed single center study. persons interested in study participation receive a neuropattern™ voucher according to occupational group together with other documents. as soon as the documents (signed informed consent, evaluation form, eri, mbi, demographic questionnaire and the form for designation of the attending physician) are returned, the study manager contacts the employee and either tells him/ her that an appointment with the designated physician should be made within the following week (neuropattern™ group) or that there will be a three months wait (control group). the employee attends the medical appointment with the designated physician and documents sent to the physician beforehand (npq-a, medical clearance form and prescription form for dexamethasone) are completed. upon return of these documents, the neuropattern™ test kit (including the questionnaires npq-p, npq-psq, npq-s and phq as well as 16 salivettes® for saliva sample collection, 0.25 mg dexamethasone and a portable ecg device) is shipped to the subject and neuropattern™ is conducted at home. after return of the test kit to daacro, the subject is assigned to neuropattern and will gain access to individualized online counseling for three months. evaluation (including an evaluation form, eri and mbi) will take place at baseline as well as three and six months after onset of online counseling for assessment of efficacy.

Eligibility criteria:
inclusion criteria: * employees aged 18 to 65 yrs * fluent in written and spoken german * medical clearance by their attending physician * signed informed consent exclusion criteria: * known intolerance to steroids * intake of steroids or benzodiazepines * pregnancy or lactation * any psychiatric diseases or current psychotherapy * acute somatic illnesses, that currently require medical treatment * obviously unsuited as subject (lack of cognitive or verbal skills) * arrhythmia absoluta * decision against the intake of dexamethasone by physician or subject (e.g. known intolerance to steroids, personal or medical reasons) * participation in any other study

Keywords: burnout subthreshold disorder
eczema reminder and accountability program

Conditions: Atopic Dermatitis; Eczema

Summary: eczema is a chronic disease that requires long term and extensive treatment. however patient adherence to the treatment plans provided to them by their healthcare providers is poor. frequent follow-up appointments have been demonstrated to improve treatment adherence, this may be due to patients feeling a sense of accountability which motivates them to adhere to their treatment. however, although frequent follow-up appointments are effective, they are not feasible. the goal of the eczema reminder and accountability program (erap) is to assess the effectiveness of a patient reminder system on patient adherence to treatment and the outcome of eczema. participants will receive weekly/biweekly text messages that encourage them to adhere to their treatment plan, and asks them to assess the severity of their eczema and adherence to treatment for that week using questionnaires. participants are then asked to send the completed questionnaires to hamilton allergy. should the erap improve eczema outcome and treatment adherence, the goal is to use the erap as a virtual follow-up to reduce the need for frequent in-office follow-ups.


Eligibility criteria:
inclusion criteria: * chronic atopic dermatitis. * age 0 to 16. exclusion criteria: -

Keywords: treatment adherence and compliance
bioavailability, pharmacokinetics and safety of esr 1150 cl in healthy adult male volunteers

Conditions: Healthy

Summary: to investigate the bioavailability of esr 1150 cl by the time course determination of plasma concentration (pharmacokinetics) of no-transformed esr 1150 after single administration to healthy adult male volunteers. secondary objective is to investigate the safety of esr 1150 cl.


Eligibility criteria:
inclusion criteria: * healthy male subjects * age: \>= 20 and \<= 35 years * weight: \>= 50 to \<= 80 kg and within +/- 20 % of standard weight * blood pressure: systolic 100 - 138 mmhg and diastolic of less than 84 mmhg * pulse rate: 45 to 80 beat/min * volunteer whose participation in the trial is judged valid by the investigator based on the results of preliminary check-up and pre-administration check-up exclusion criteria: * history of diseases including cardiac, pulmonary, hepatic, renal or gastrointestinal disease * history of drug allergy * history of drug dependency, alcohol dependency, etc. * use of other trial drug within 6 months before study drug administration * use of any drugs within 7 days before study drug administration
high flow therapy for the treatment of respiratory failure in the ed

Conditions: Acute Respiratory Failure

Summary: the overall objective of this study is to determine if vapotherm high flow nasal cannula therapy (hft), when used to treat respiratory failure in the ed, is at least equivalent to the current standard of care for non-invasive ventilatory support, non-invasive positive pressure mask ventilation (nippv). moreover, this study will investigate the potential that hft has possible advantages over nippv, such as decreased time to patient stability from respiratory failure, and the ease of use as a first line intervention for respiratory failure in the ed environment. the hypothesis is that hft via the vapotherm precision flow will demonstrate clinical non-inferiority when compared to nippv with regard to treatment failure by way of an impact on ventilation indices and a lower intolerance rate, and have a positive association with hospital disposition and length of stay.


Eligibility criteria:
inclusion criteria: * adult patients (\> 18 yrs of age) * presentation with acute respiratory failure according to the following criteria: * if any of these are present: respiratory rate \>22 or labored; suspected acute respiratory acidosis, as defined as ph \<7.32 on initial blood gas(either arterial or venous); hypoxemia, as defined as pulse ox \<92%; * clinical decision to escalate therapy to non-invasive ventilatory support, or to maintain non-invasive ventilatory support if delivered to the ed on such. exclusion criteria: * suspected drug overdose * cardiovascular instability as demonstrated by hypotension relative to initial clinical presentation that requires immediate intervention * end stage cancer * life expectancy \< 6 months * respiratory arrest or significant respiratory depression on presentation * glasgow coma scale score \< 9 * cardiac arrest on initial presentation * need for emergent intubation * known or suspected cerebrovascular accident * known or suspected st segment elevation myocardial infarction * patients with increased risk of pulmonary aspiration * agitation or uncooperativeness

Keywords: high flow therapy high flow nasal cannula acute respiratory failure noninvasive ventilation
low dose colchicine in patients with peripheral artery disease to address residual vascular risk

Conditions: Peripheral Arterial Disease; Atherosclerosis of Extremities; Inflammation

Summary: the low dose colchicine in patients with peripheral artery disease to address residual vascular risk (leader-pad) trial will evaluate if anti-inflammatory therapy with colchicine will reduce vascular events in patients with symptomatic peripheral artery disease.

the leader-pad trial is a randomized, double blind, multicenter trial with an active run-in period, comparing low dose colchicine 0.5 mg daily with placebo in patients with symptomatic peripheral artery disease (pad) to prevent vascular events (myocardial infarction, stroke, cardiovascular deaths, acute limb ischemia and vascular amputation). the sample size for the trial is 6,150 participants. the primary outcome for the trial is major adverse cardiovascular and limb events (mace and male). this composite outcome consists of cardiovascular death, myocardial infarction, stroke and severe limb ischemia that requires a vascular intervention (i.e., pharmacological reperfusion, endovascular or surgical revascularization) or a major vascular amputation (defined as ankle/transtibial amputation or higher).

Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. symptomatic atherosclerotic le pad fulfilling at least one of the following: a. intermittent claudication with ankle/arm blood pressure ratio\* (abi ≤ 0.90) or artery stenosis ≥ 50% plus one of i. \>1 vascular bed affected by atherosclerosis ii. diabetes iii. heart failure iv. chronic kidney disease (egfr \< 60 ml/min/1.73 m2) b. rest pain (mostly in foot) or necrosis of limb or gangrene of limb (corresponding to either fontaine stages 3 or 4 or rutherford classification categories 4 to 6). all must have an ankle/arm blood pressure ratio\* (abi ≤ 0.90) or artery stenosis ≥ 50%. \* in cases of incompressible ankle arteries, the presence of toe pressure ≤ 60 mm hg or toe-brachial index ≤ 0.70 is acceptable c. revascularization defined as limb bypass surgery or endovascular revascularization procedures (irrespective of the specific device used), including percutaneous transluminal angioplasty/stent of iliac or infra-inguinal arteries or extra-anatomical bypass surgery d. leg or foot amputation for arterial vascular indications 3. written or verbal informed consent from the patient exclusion criteria: 1. contraindication to colchicine 2. long term requirement for colchicine for another clinical indication 3. active diarrhoea 4. egfr \< 30 ml/min/1.73 m2 5. cirrhosis or severe chronic liver disease 6. woman who is pregnant, or breast-feeding or of child-bearing potential not protected by reliable contraception or is planning conception during the study 7. current or planned long term use of cyclosporine, verapamil, hiv protease inhibitors, azole antifungals, or macrolide antibiotics (with the exception of azithromycin) 8. patients who are deemed unlikely to return for follow-up 9. patients with life expectancy \< 1 year

Keywords: acute limb ischemia myocardial infarction stroke cardiovascular death mortality
a study on the efficacy and safety of multi-mode ablation combined with systemic therapy in the treatment of crclm

Conditions: Colorectal Cancer Liver Metastasis

Summary: the goal of this study is to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including pd-1(programmed death receptor 1) inhibitor for colorectal cancer liver metastasis and furthermore to clarify its application value by comparing preoperative and postoperative immune indicators.

this is a single-center, single-arm, prospective study to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including pd-1 inhibitor in the treatment of colorectal cancer liver metastasis. the study includes 20 patients with colorectal cancer liver metastasis that has failed first-line therapy and is unresectable. all patients will receive multi-mode ablation to achieve complete remission of liver lesions followed by systemic therapy including pd-1 inhibitor. this study will provide preliminary data on the efficacy and safety of multi-mode ablation combined with systemic therapy including pd-1 inhibitor in the treatment of colorectal cancer liver metastasis, which could lead to larger randomized trials.

Eligibility criteria:
inclusion criteria: 1. age 18-75 years, gender not specified; 2. pathologically or clinically confirmed colorectal cancer liver metastases, with liver lesions unsuitable for surgical resection or intolerance or refusal of surgical resection; 3. in the case of an unresectable primary tumor or recurrence, the absence of serious complications such as bleeding or obstruction; 4. failure of first-line treatment, with disease progression or new liver metastases; 5. no more than 5 liver lesions, with single lesion diameter ≤ 3cm; 6. for those who have received previous chemotherapy, radiotherapy or local liver treatment, the interval from the last systemic treatment or local liver treatment should be at least 1 month; 7. child-pugh a or b; bilirubin ≤ 3.0 mg/dl, creatinine ≤ 2.5 mg/dl, white blood cell count ≥ 2.0 ×10\^9/l, platelets ≥ 100 ×10\^9/l; 8. ecog ps ≤ 2; 9. willing to accept subsequent treatment regimens that include anti-pd-1 monoclonal antibody therapy. exclusion criteria: 1. liver function child-pugh class c; 2. expected survival \< 3 months; 3. major organ insufficiency or failure; 4. active infection; 5. irreversible coagulation disorders; 6. refractory massive ascites, pleural effusion or cachexia; 7. unable to cooperate with treatment; 8. any other factors deemed inappropriate for inclusion or that may affect the subject's participation in the study, as determined by the investigator.
voice telerehabilitation

Conditions: Vocal Fold Palsy

Summary: the aim of the study was to determine functional results of telerehabilitation (tr) in subjects affected by iatrogenic unilateral vocal fold paralysis (uvfp) during the covid-19 pandemic outbreak. 40 patients with iatrogenic unilateral vocal fold paralysis underwent voice teletherapy with a synchronous approach. a multidimensional assessment by means of videolaryngostroboscopy, acoustic and perceptual analysis and patient self-assessment was carried out before, at the end of teletherapy and six months later.


Eligibility criteria:
inclusion criteria: * age between 18-75 years * onset of uvfp less than 1 month before * internet access * availability and ability to use a computer with an internal or external webcam. exclusion criteria: * previous history of laryngeal pulmonary or gastric surgery * current or previous pulmonary diseases * hearing loss, neurological or motor deficits * reading difficulties * dysphagia * unavailability of a computer and a webcam.
effectiveness of extracorporeal shockwave therapy combined with platelet-rich plasma in the treatment of chronic insertional achilles tendinopathy

Conditions: Insertional Achilles Tendinopathy

Summary: the goal of this clinical trial is to learn about the effectiveness of extracorporeal shockwave(eswt) combined with platelet-rich plasma(prp) to treat chronic insertional tendinopathy. the main questions it aims to answer are: does eswt combined with prp treatment reduce the symptom and improve functional score after treatment? what medical complication do participants have when receive the treatment? researchers will compare eswt combined with prp to eswt treatment alone to see if eswt combined with prp works to treat chronic insertional tendinopathy. participants will: * receive eswt once a week for 4 weeks then receive prp injection at a week later or eswt once a week for 4 weeks * visit the clinic at 6 weeks, 3 months, 6 months and 1 year after treatment for checkups and record functional score


Eligibility criteria:
inclusion criteria: * diagnosed with insertional achilles tendinopathy * had symptom more than 6 months * failed other standard conservative treatment (rest, medication, activity modification, stretching exercise, and heel lift orthosis) exclusion criteria: * receive corticosteroid injection at the achilles insertion * history of infection around ankle and heel * has neurological deficit * has a contraindication for eswt(hemophilia, coagulopathy or foot and ankle malignancy)

Keywords: chronic insertional achilles tendinopathy extracorporeal shockwave therapy platelet rich plasma
intravitreal aflibercept injection in vitrectomized eyes for treatment of diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: this a non-interventional retrospective study on the efficiency and the tolerance of intravitreal injections of aflibercept on vitrectomized eyes in the diabetic macular oedema

diabetic macular edema (dme) is the leading cause of blindness among people of working age. treatment of dme included blood pressure and glycemic control, grid laser, intravitreal injection of steroids (acetonide of triamcinolone, dexamethasone implant, fluocinolone implant) or anti-vascular endothelial growth factor (vegf) therapy (bevacizumab, ranibizumab, aflibercept) (2015). the advent of anti-vegf therapy has revolutionized the management of dme. aflibercept, one of the drugs in this group has recently been approved in france. however, there is no report in the efficacy and tolerance of aflibercept in vitrectomized eyes in the diabetic macular oedema . in this study, in order to prove the efficiency and tolerance of aflibercept, data will be collected in a anonymous way in medical records of patients having received a treatment by aflibercept in the past.

Eligibility criteria:
inclusion criteria: * diabetic patients aged between 19 and 90 years old * patients with the following characteristics at the beginning of the aflibercept therapy : hba1c \< 9% diabetic macular oedema with the central affected visual acuity between 1/20 and 5/40 (between 20 and 70 letters etrs) patients who had a vitrectomy over 3 months ago * patients who did not received an anti-vegf treatment or any other treatment for their diabetic macular edema 3 months before the beginning of the injections exclusion criteria: * patients who refused the collection of their data in medical records * patients with a macular ischemia of more than 1500µm diagnosed via an avascular central fluorescein angiography before the inclusion * patients with a recent cardiovascular incident (heart attack, stroke dating for less than 3 months before the inclusion) * pregnancy at the moment of inclusion

Keywords: diabetic retinopathy intravitreal aflibercept
treatment protocol of voraxaze for patients experiencing or at risk of methotrexate toxicity

Conditions: Neoplasms

Summary: this protocol is for the treatment of toxic plasma methotrexate concentrations (\>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function

this treatment protocol will be available on a cost recovery basis to irb-approved investigators treating an eligible patient at any site in the us. in order to continue to make voraxaze™ available following fda approval and prior to being commercially available. protherics needs to charge for the product, so there will be a cost to obtain voraxaze™ under the open-label treatment protocol. protherics is permitted under the fda regulations (21 cfr 312.8) to charge for voraxaze, to recover those costs associated with its manufacture, research and development, and handling, but do not include other commercial costs (profit). patient eligibility is based on mtx concentrations and laboratory values obtained per standard of care. once an investigator identifies a potential patient, he/she will contact the voraxaze central call center (1-877-398-9829) to receive information regarding drug shipment. eligible patients will have routine demographic, mtx, and voraxaze therapy information collected. each patient will receive a single dose of voraxaze 50 units/kg in a bolus intravenous injection over 5 minutes. in addition to voraxaze, patients will continue to receive standard of care treatment including leucovorin therapy, and supportive care such as hydration, alkalinization of urine and, if necessary, hemoperfusion/dialysis.

Eligibility criteria:
inclusion criteria: * male or female patients of any age who are experiencing delayed mtx clearance due to impaired renal function will be eligible to receive voraxaze if the have toxic plasma mtx concentrations (\>1 micromole per liter). exclusion criteria: * voraxaze is not indicated for use in patients who exhibit the expected clearance of mtx (plasma mtx concentrations within 2 standard deviations of the mean mtx excretion curve specific for the dose of mtx administered) or those with normal or mildly impaired renal function because of the potential risk of sub therapeutic exposure to mtx. * patients with known hypersensitivity to voraxaze (glucarpidase, carboxypeptidases) patients intolerant to lactose in food (e.g., dairy products) can still receive voraxaze.

Keywords: voraxaze glucarpidase carboxypeptidase cancer lymphoma leukemia osteosarcoma methotrexate delayed elimination renal insufficiency toxicity